Fixation implant and method

ABSTRACT

A fixation implant and associated methods are presented. The fixation implant includes first and second ends, each of which is separable from the implant body and useable to fix a material relative to a bone.

FIELD OF THE INVENTION

The invention relates to fixation implants and methods for making and using them.

BACKGROUND

Various conditions may affect skeletal joints such as the elongation, shortening, detachment or rupture of soft tissues associated with the joint. Joint function may be restored by reconstruction of the soft tissues associated with the joint for example by reattaching soft tissue and/or fixing grafts at the joint.

SUMMARY

The present invention provides fixation implants and methods for making and using them.

In one aspect of the invention, a fixation implant includes an elongated shaft extending from a first end portion to a second end portion and having an intermediate portion between the first and second end portions. The intermediate portion is substantially smooth and the end portions are threaded. The shaft is made of a polymer and the first and second end portions are separable from the intermediate portion by cutting.

In another aspect of the invention, a method of reconstructing soft tissue of a metapodial phalangeal joint of a human extremity having a metapodial bone and a proximal phalanx includes forming a metapodial bone tunnel in the metapodial bone, forming a phalangeal bone tunnel in the proximal phalanx, placing a graft between the metapodial and phalangeal bone tunnels, threading a first end of a double ended fixation implant into one of the metapodial bone tunnel and phalangeal bone tunnel in interference fashion to secure the graft relative to the bone tunnel, separating the first end from a shaft of the fixation implant, threading a second end of the fixation implant into the other of the metapodial bone tunnel and phalangeal bone tunnel in interference fashion to secure the graft relative to the bone tunnel, and separating the second end from the shaft of the fixation implant.

In another aspect of the invention, a method of attaching material adjacent to a metapodial phalangeal joint of a human extremity having a metapodial bone and a proximal phalanx includes forming a metapodial bone tunnel in the metapodial bone, connecting a suture to the material to be attached, placing the suture in the metapodial bone tunnel, threading a first end of a double ended fixation implant into the metapodial bone tunnel in interference fashion to secure the suture relative to the bone tunnel, and separating the first end from a shaft of the fixation implant.

BRIEF DESCRIPTION OF THE DRAWINGS

Various examples of the present invention will be discussed with reference to the appended drawings. These drawings depict only illustrative examples of the invention and are not to be considered limiting of its scope.

FIG. 1 is a side elevation view of the human foot illustrating anatomic reference planes;

FIG. 2 is a dorsal view of the metatarsus and proximal phalanx of the right second metatarsophalangeal joint of the human foot;

FIG. 3 is a medial view of the bones of FIG. 2;

FIG. 4 is a lateral view of the bones of FIG. 2;

FIG. 5A is a perspective view of an illustrative example of a fixation implant according to the present invention;

FIG. 5B is a side detail view of the fixation implant of FIG. 5A;

FIG. 5C is a side elevation view of the fixation implant of FIG. 5A loaded into a driver;

FIGS. 6-12 are side elevation views illustrating steps in a soft tissue reconstruction procedure utilizing the fixation implant of FIG. 5A;

FIG. 13 is a side elevation view illustrating a soft tissue reconstruction procedure utilizing the fixation implant of FIG. 5A; and

FIG. 14 is a side elevation view illustrating a soft tissue reconstruction procedure utilizing the fixation implant of FIG. 5A.

DESCRIPTION OF THE ILLUSTRATIVE EXAMPLES

The following illustrative examples illustrate fixation implants and methods for making and using them. Implants and methods according to the present invention may be used in conjunction with any surgical fixation procedure but the illustrative examples are shown in a size and form most suitable for fixing native soft tissue and grafts used to reconstruct the soft tissues of joints of the hand and foot. In particular, the illustrative examples depict their use on metatarsophalangeal (MTP) joints of the human foot. The illustrative implants and methods are also suitable for use on metacarpophalangeal (MCP) joints of the human hand. The hand and foot have a similar structure. Each has a volar aspect. In the hand the volar, or palmar, aspect includes the palm of the hand and is the gripping side of the hand. In the foot the volar, or plantar, aspect is the sole of the foot and is the ground contacting surface during normal walking. Both the hand and foot have a dorsal aspect opposite the volar aspect. Both the hand and foot include long bones referred to as metapodial bones. In the hand, the metapodial bones may also be referred to as metacarpal bones. In the foot, the metapodial bones may also be referred to as metatarsal bones. Both the hand and foot include a plurality of phalanges that are the bones of the digits, i.e. the fingers and toes. In both the hand and foot, each of the most proximal phalanges forms a joint with a corresponding metapodial bone. This joint includes a volar plate or band of connective tissue on the volar side of the joint. The joint also includes collateral ligaments on the medial and lateral sides of the joint. A transverse ligament connects the heads of the metapodial bones. In the hand the joint is typically referred to as the metacarpophalangeal joint having a palmar plate on the palmar side, collateral ligaments medially and laterally, and a transverse ligament connecting the metacarpals. In the foot the joint is typically referred to as the metatarsophalangeal joint having a plantar plate on the plantar side, collateral ligaments medially and laterally including proper collateral ligaments and accessory collateral ligaments, and a transverse ligament also known as the transverse metatarsal ligament.

For convenience, the illustrative examples depict the use of devices and techniques according to the present invention to fix soft tissue and grafts used to reconstruct the metatarsophalangeal (MTP) joints of the human foot. The devices and techniques may be used to fix soft tissue or grafts directly and/or they may be used to fix an intermediate material connected to the soft tissue or graft, e.g. a suture strand, leader, sheath, or other intermediate material. The illustrative devices and techniques are also suitable for use on metacarpophalangeal (MCP) joints of the human hand and at other surgical sites. To better orient the reader, the MTP joint and basic anatomic references are explained in more detail below.

FIG. 1 illustrates the anatomic planes of the foot that are used for reference in this application. The coronal plane 10 extends from the medial aspect 12 to the lateral aspect of the foot and from dorsal 14 to plantar 16 and divides the foot between the toes and heel. The sagittal plane 18 extends anterior 20 to posterior 22 and dorsal 14 to plantar 16 and divides the foot into medial and lateral halves. The transverse plane 24 extends anterior 20 to posterior 22 and medial to lateral parallel to the floor 26.

FIGS. 2-4 illustrate the metatarsus 30 and proximal phalanx 50 of the second MTP joint of the right foot. The medial and lateral epicondyles 32, 34, located on the medial-dorsal and lateral-dorsal aspects of the metatarsus 30 respectively, are the origins of the medial and lateral proper collateral ligaments (PCLs) 36, 38 and the medial and lateral accessory collateral ligaments (ACLs) 40, 42 of the MTP joint. The medial PCL inserts at the medial-plantar aspect 52 and the lateral PCL inserts at the lateral-plantar aspect 54 of the proximal phalanx 50. The ACLs fan out and insert into the plantar plate 44. The metatarsus includes a metatarsal head 46 having an articular surface 48 and the proximal phalanx includes a phalangeal head 56 having an articular surface 58. The metatarsus 30 further includes a longitudinal axis 60 extending lengthwise down the center of the bone.

FIGS. 5A-5C illustrate an exemplary fixation implant 100 according to the present invention. The implant 100 includes an elongated shaft 102 having a longitudinal axis 104 and extending from a first end portion 106 to a second end portion 108. An intermediate portion 110 is positioned between the first and second end portion 106, 108. In the illustrative example of FIGS. 5A-C, the intermediate portion 110 is a smooth cylinder suitable for engaging with the chuck of a wire driver 111 and the first and second end portions 106, 108 are threaded to engage a tunnel in a bone. The end portions 106, 108 are separable from the implant, such as by cutting, to permit first one end and then the other to be implanted into a bone tunnel. The implant may be constructed of any biocompatible material that will permit the end portions to be cut to separate them from the rest of the implant. Such materials include metals, polymers, bone, and other suitable materials. Preferably the implant is made of a polymer. More preferably the implant is made of a high performance thermoplastic such as members of the aromatic ketone family of polymers including such polymers as polyetherketone (PEK), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and other aromatic ketones.

The first end portion 106 has a length 112, the intermediate portion 110 has a length 114, and the second end portion 108 has a length 116 all measured parallel to the longitudinal axis 104. In the illustrative example of FIGS. 5A-5C, the length of the end portions 106, 108 are sized for the longest bone tunnel in which they are expected to be used to provide full threaded engagement over the length of the bone tunnel. The end portions may be the same length, as shown, or they may have different lengths, e.g. if a surgical procedure requires bone tunnels of substantially different length. By sizing for the longest tunnel expected, and not longer, length is preserved for the smooth intermediate portion without making the overall pin length unnecessarily long. In this way the implant is optimized for threaded engagement of the end portions 106, 108 and driver engagement of the intermediate portion. In the illustrative example of FIGS. 5A-5C, the ratio of the length of the intermediate portion to the length of the end portions is in the range of approximately 1:1 to 16:1, preferably in the range of 3:1 to 6:1, and more preferably in the range of 4:1 to 5:1. For example, in the illustrative implant of FIGS. 5A-5C useful for fixing soft tissue and reconstructive grafts in or adjacent bone tunnels during hand and foot surgery, the end portions are each in the range of approximately 5-18 mm, preferably in the range of 8-15 mm, and more preferably in the range of 10-13 mm while the intermediate portion is in the range of approximately 20-80 mm, preferably in the range of 40-60 mm, and more preferably in the range of 45-55 mm.

In the illustrative example of FIGS. 5A-5C, the end portions 106, 108 are generally cylindrical in outline over most of their length with a conical taper over the terminal portion of the end portion. The taper comes to a blunt point 118 so that the taper is generally frustoconical in shape. The taper length 119 is approximately 5 to 30 percent of the length of each end portion, preferably 10-30 percent of the length, more preferably 15-30 percent of the length.

In the illustrative example of FIGS. 5A-5C, the threads of the end portions 106, 108 are generally flat topped having a major diameter 120, a minor diameter, a pitch 122, a crest width 124, and an intercrest spacing 126. It has been found that secure fixation may be achieved with major diameter 120 to pitch 122 ratios in the range of 0.5:1 to 4:1, preferably 1:1 to 3:1, more preferably 1.5:1 to 2.5:1. In the illustrative example of FIGS. 5A-5C, the major diameter to pitch ratio is approximately 2:1. The crest width 124 influences whether the threads cut into the bone tunnel walls and the repair material, press into them, or merely slide over them. It has been found that good fixation without damage to the soft tissue, graft, or attached sutures occurs when the thread intercrest spacing 126 to crest width 124 ratio is in the range of 1:1 to 3:1, preferably 1.5:1 to 2.5:1. In the illustrative example of FIGS. 5A-5C the intercrest spacing to crest width ratio is approximately 2:1. For example, in the illustrative example of FIGS. 5A-5C, the threads have a major diameter of approximately 1.6 mm, a crest width of approximately 0.26 mm, an intercrest spacing of approximately 0.51 mm, a pitch of approximately 0.76 mm, a threaded portion length 112 of approximately 11.4 mm, and a taper length of approximately 2.16 mm.

FIGS. 6-12 depict an illustrative surgical method utilizing the fixation implant of FIGS. 5A-5C. In the illustrative example of FIGS. 6-12, the implant is shown in use to fix a graft, e.g. a fibrous synthetic graft, used to reconstruct a collateral ligament of a metapodial/phalangeal joint of an extremity of a human patient. In this example, the ligament is the lateral PCL of an MTP joint of a human foot. A tunnel 130 has been formed in the metatarsal bone 132 approximately at the anatomic origin of the lateral PCL. A tunnel 134 has been formed in the proximal phalanx 136 approximately at the insertion of the lateral PCL. A graft passer 138 having a loop 140 is passed through the metatarsal tunnel 130 and an end portion 204 of a graft 200 is inserted through the loop 140.

Referring to FIG. 7, the graft passer 138 has been withdrawn pulling the end portion 204 into the tunnel 130. The tunnel 130 is sized for a press fit with an intermediate portion 202 of the graft 200. Because the end portion 204 has a reduced cross sectional area, it is able to fold around the loop 140 and be pulled through the tunnel 130 in a doubled over configuration which allows it to be pulled through the tunnel 130 and without becoming disengaged from the loop 140.

Referring to FIG. 8, the end portion 204 has been pulled through the bone and may be advanced further with the graft passer or by gripping the end portion directly or with another instrument to position the end of the intermediate portion in the bone tunnel.

Referring to FIG. 9, one end of the implant 100 has been threaded into the bone tunnel 130 to secure the graft 200 in the bone tunnel in interference fashion with the threads of the implant 100 pressing into the bone tunnel wall and the graft 200. The other end of the graft 204 has been passed through the tunnel 134 in the proximal phalanx 136.

Referring to FIG. 10, the implant has been cut flush with the bone surface in preparation for using the other threaded end to fix the graft 200 in the proximal phalanx 136.

Referring to FIG. 11, the remaining end of the implant 100 has been threaded into the bone tunnel 134 to secure the graft 200 in the bone tunnel in interference fashion with the threads of the implant 100 pressing into the bone tunnel wall and the graft 200.

Referring to FIG. 12, the implant has been cut flush with the bone and excess portions of both ends of the graft 200 have been cut and removed from the surgical site.

Referring to FIG. 13, a graft 300, e.g. a tissue graft, has sutures 302 attached, e.g. by stitching, to its ends. As described above, a graft passer 138 having a loop is used to pass the sutures 302 into the bone tunnels 130, 134. However, in the illustrative example of FIG. 13, the sutures 302 and not the graft are fixed in the bone tunnel by the fixation implant 100 and the sutures 302 support the graft. Similarly, the fixation implant 100 may be used to fix sutures that are attached to torn, stretched, or detached native soft tissues in order to reattach and/or repair the native soft tissues.

Referring to FIG. 14, a collateral ligament has been released or avulsed from its origin on the metatarsal bone 132. For example, the ligament may be released to provide enhanced access to another part of the joint to facilitate a surgical repair such as for example to gain access to the plantar plate. Alternatively, an injury or chronic condition may have led to the ligament becoming detached from its anatomic origin. In the illustrative example of FIG. 14, the lateral PCL 38 has been detached to provide access for a primary surgical procedure. After the primary surgical procedure has been accomplished, the lateral PCL 38 is reattached by forming a bone tunnel 130 in the metatarsal bone 132, attaching sutures 400 to the free end of the ligament, passing the sutures into, or through as shown in the illustrative example of FIG. 14, the bone tunnel 130, tensioning the sutures, and fixing the sutures with the fixation implant 100. For example, the fixation implant 100, may be threaded into the bone tunnel 130 to form an interference fit between the bone and suture 400 and lock the sutures in place. The portion of the fixation implant 100 protruding from the bone is then cut off and the other end of the fixation implant 100 may be used to fix other material. For example in a bilateral procedure the other end of the fixation implant 100 may be used to fix sutures connected to the medial collateral ligament.

The illustrative examples have depicted a fixation implant constructed and used for graft fixation in reconstruction of an MTP joint of a human foot. The graft and methods of the present invention are suitable for grafting at other locations within a patient's body including, but not limited to, the MCP joints of the human hand. 

What is claimed is:
 1. A fixation implant comprising: an elongated shaft having a longitudinal axis and extending from a first end portion to a second end portion and having an intermediate portion between the first and second end portions, the intermediate portion being substantially smooth and the end portions being threaded, the shaft being made of a polymer, and the first and second end portions being separable from the intermediate portion by cutting.
 2. The fixation implant of claim 1 wherein the first end portion has a first end portion length, the intermediate portion has an intermediate portion length, and the second end portion has a second end portion length all measured parallel to the longitudinal axis, the ratio of the length of the intermediate portion to the length of the first end portion being in the range of approximately 1:1 to 16:1.
 3. The fixation implant of claim 2 wherein the ratio of the length of the intermediate portion to the length of the first end portion being in the range of 3:1 to 6:1.
 4. The fixation implant of claim 2 wherein the ratio of the length of the intermediate portion to the length of the first end portion being in the range of 4:1 to 5:1.
 5. The fixation implant of claim 2 wherein first end portion length and the second end portion length are approximately equal.
 6. The fixation implant of claim 1 wherein the first end portion has a first end portion length, the intermediate portion has an intermediate portion length, and the second end portion has a second end portion length all measured parallel to the longitudinal axis, the first end portion length being in the range of approximately 5-18 mm and the intermediate portion length being in the range 20-80 mm.
 7. The fixation implant of claim 6 wherein the first end portion length is in the range of 8-15 mm and the intermediate portion length is in the range of 40-60 mm.
 8. The fixation implant of claim 6 wherein the first end portion length is in the range of 10-13 mm and the intermediate portion length is in the range of 45-55 mm.
 9. The fixation implant of claim 1 wherein the end portion threads have flat topped thread crests and have a major diameter, a pitch, a crest width, and an intercrest spacing.
 10. The fixation implant of claim 9 wherein the major diameter to pitch ratio is in the range of 0.5:1 to 4:1 and the intercrest spacing to crest width ratio is in the range of 1:1 to 3:1.
 11. A method of attaching material adjacent to a metapodial phalangeal joint of a human extremity, the joint including a metapodial bone and a proximal phalanx, the method comprising: forming a bone tunnel in a first bone; approximating the material near the bone tunnel; threading a first end of a double ended fixation implant into the bone tunnel in interference fashion to secure the material relative to the bone tunnel; and separating the first end from a shaft of the fixation implant.
 12. The method of claim 11 wherein forming a bone tunnel comprises forming a metapodial bone tunnel in the metapodial bone and wherein the material is a graft, the method further comprising: forming a phalangeal bone tunnel in the proximal phalanx; placing the graft between the metapodial and phalangeal bone tunnels during the step of approximating the material near the first bone tunnel; threading the first end of the double ended fixation implant into one of the metapodial bone tunnel and the phalangeal bone tunnel during the step of threading a first end; threading a second end of the fixation implant into the other of the metapodial bone tunnel and the phalangeal bone tunnel in interference fashion to secure the graft relative to the bone tunnel; and separating the second end from the shaft of the fixation implant.
 13. The method of claim 11 wherein the metapodial bone is a metatarsal bone and the metapodial phalangeal joint is an MTP joint of a human foot and the metapodial bone tunnel intersects the origin of a proper collateral ligament and the phalangeal bone tunnel intersects the insertion of the proper collateral ligament.
 14. The method of claim 11 wherein the metapodial bone is a metatarsal bone and the metapodial phalangeal joint is an MTP joint of a human foot and the metapodial bone tunnel intersects the origin of an accessory collateral ligament and the phalangeal bone tunnel intersects the insertion of the accessory collateral ligament.
 15. The method of claim 11 wherein the double ended fixation implant comprises an elongated shaft having a longitudinal axis and extending from a first end portion to a second end portion and having an intermediate portion between the first and second end portions, the intermediate portion being substantially smooth and the end portions being threaded, the shaft being made of a polymer, and the first and second end portions being separable from the intermediate portion by cutting.
 16. The method of claim 11 further comprising: forming a metapodial bone tunnel in the metapodial bone during the step of forming a bone tunnel; connecting a suture to the material to be attached; placing the suture in the metapodial bone tunnel; and securing the suture in the bone tunnel during the step of threading a first end of a double ended fixation implant into the bone tunnel.
 17. The method of claim 15 wherein the material to be attached is a joint tissue that has become detached from its origin on the metapodial bone.
 18. The method of claim 16 wherein the joint tissue comprises a collateral ligament.
 19. The method of claim 17 wherein the collateral ligament is one of a medial and lateral collateral ligament and connecting a suture to the material to be attached comprises: connecting a suture to the other of the medial and lateral collateral ligament; placing the suture in a metapodial bone tunnel; threading the second end of the double ended fixation implant into the metapodial bone tunnel in interference fashion to secure the suture relative to the bone tunnel; and separating the second end from the shaft of the fixation implant.
 20. The method of claim 15 wherein the material to be attached is a graft, the method further comprising forming a phalangeal bone tunnel in the proximal phalanx, connecting a suture to the material to be attached comprises connecting a first suture to a first end of the graft and connecting a second suture to a second end of the graft, placing the suture in the metapodial bone tunnel comprises placing the first suture in the metapodial bone tunnel and the method further comprises placing the second suture into the phalangeal bone tunnel, the method further comprising threading a second end of the fixation implant into the phalangeal bone tunnel in interference fashion to secure the second suture relative to the bone tunnel, and separating the second end from the shaft of the fixation implant.
 21. The method of claim 15 wherein placing the suture in the metapodial bone tunnel comprises passing the suture through the bone tunnel from a first bone tunnel opening to a second, opposite bone tunnel opening and wherein threading a first end of a double ended fixation implant into the metapodial bone tunnel comprises threading the first end into the second bone tunnel opening and advancing it toward the first bone tunnel opening.
 22. The method of claim 15 wherein the double ended fixation implant comprises an elongated shaft having a longitudinal axis and extending from a first end portion to a second end portion and having an intermediate portion between the first and second end portions, the intermediate portion being substantially smooth and the end portions being threaded, the shaft being made of a polymer, and the first and second end portions being separable from the intermediate portion by cutting. 